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Novartis, BioE In Typhoid Vaccine Deal

Novartis has entered into a development and licensing agreement with India-based Biological E Limited (BioE) for two vaccines to protect against typhoid and paratyphoid fevers. Novartis has a goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions and this new collaboration further advances the pharma company towards its goal.

In just five years, the Novartis Vaccines Institute for Global Health (NVGH), part of the Novartis Institutes for BioMedical Research, has developed a typhoid vaccine with funding by the Fondazione Monte dei Paschi di Siena and Regione Toscana through the Sclavo Vaccines Association (Italy). The typhoid vaccine (Vi-CRM197) has already achieved Proof of Concept and has had successful Phase 2 clinical trial results, and will be transferred to BioE.

Under terms of the agreement, NVGH will transfer technology to BioE, who will then have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world.

"NVGH uses its innovative know-how to tackle important problems in public health. BioE has a proven track record in vaccine manufacture, and capabilities to clinically develop and deliver WHO pre-qualified affordable vaccines to the developing world. We are pleased to be working with them to address this unmet need."

Don Ganem, VP and Global Head of Infectious Diseases, Novartis Institutes for BioMedical Research.

BioE is committed to achieving World Health Organization (WHO) pre-qualification and fulfill specific obligations to meet Novartis standards. The agreement is worldwide except for developed countries, where Novartis will retain rights.

There are approximately 21 million cases of typhoid fever and five million cases of paratyphoid A fever reported globally in a year. Many victims are children under the age of two as there is no widely available typhoid vaccine. No vaccine is available for any age group against paratyphoid fever.

Related news:

Novartis, BioE join hands for typhoid, paratyphoid vaccines (Economic Times)

Reference links:

Novartis press release

ICMR Invites EoI For Joint Development & Commercialization Of Typhoid & Paratyphoid Vaccine

The Indian Council of Medical Research (ICMR) has issued an Expression of Interest (EoI) for the joint development and commercialization of a broad-specificity typhoid and paratyphoid vaccine.

This aims to engage eligible organizations, companies, and manufacturers in a collaborative effort to develop a vaccine targeting Salmonella Typhi, Salmonella Paratyphi, and Salmonella Typhimurium, the primary pathogens responsible for enteric fever.

Typhoid and paratyphoid fevers, collectively known as enteric fever, continue to pose a major public health challenge in India and globally, leading to significant morbidity and mortality. Despite advancements in healthcare, antimicrobial resistance has complicated treatment strategies, making vaccination the most effective tool for prevention. Recognizing this urgent need, ICMR-National Institute for Research in Bacterial Infections (NIRBI), Kolkata has developed a vaccine technology based on Outer Membrane Vesicles (OMVs) derived from two distinct strains of typhoidal Salmonella species.

By initiating this EoI, ICMR seeks to bridge the gap between cutting-edge scientific research and large-scale vaccine production, ensuring the development of a broad-specificity vaccine that is effective against multiple strains of Salmonella.

The primary objectives of the initiative are validation of the developed technology. ICMR aims to scientifically validate the broad-specificity vaccine against Salmonella Typhi and Salmonella Paratyphi, collaborating with private or public-sector partners to enhance the vaccine's effectiveness and ensure regulatory compliance, licensing the technology to eligible manufacturers to enable large-scale vaccine production and distribution, ensuring that the vaccine reaches populations most vulnerable to typhoid and paratyphoid infections.

ICMR envisions a two-phased approach for this collaboration. The selected partner organizations will undertake independent validation of the vaccine technology developed by ICMR-NIRBI, ensuring its safety, immunogenicity, and efficacy.

This phase will involve laboratory research, preclinical studies, and initial regulatory documentation to pave the way for clinical trials.

Partners will engage in joint R&D activities, including further refinement of the vaccine candidate, upscaling production capabilities, and obtaining necessary regulatory approvals. The collaboration will facilitate clinical trials to assess the vaccine's effectiveness in diverse population groups.

Upon successful validation and approval, the vaccine will be mass-produced and marketed for national and international use. ICMR will serve as the key facilitator in this partnership, offering comprehensive support.

ICMR-NIRBI scientists will provide insights, guidance, and technical oversight in vaccine production. From study design to data analysis, ICMR will assist in the development of protocols, safety assessments, and efficacy evaluations. Through its network of affiliated research institutes, ICMR will support the conduct of preclinical and clinical trials across multiple sites in India, helping partners navigate India's regulatory landscape to ensure smooth approvals for commercialization.

Medications And Drugs For Treatment Of Typhoid And Paratyphoid Enteric Fevers

Typhoid and Paratyphoid Enteric Fevers are caused by bacteria called Salmonella typhi. Causes, symptoms, diagnosis and treatment of Typhoid and Paratyphoid Enteric Fevers are discussed.

Typhoid Vaccine Live

Typhoid Vaccine Live is an active immunization against typhoid fever caused by the bacterium Salmonella typhi.

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